Singapore legislation
Regulation 26
Regulation 26
Evaluation process
Subregulation 1
For the purposes of section 33 of the Act, the Authority may, upon an application for the registration of a medical device —
evaluate the medical device under —
an abridged evaluation process; (ii)an expedited abridged evaluation process; (iii)a full evaluation process; or
a priority full evaluation process; or
immediately register the medical device.
Subregulation 2
A medical device may qualify for evaluation under an abridged evaluation process, if —
any competent regulatory agency of a foreign jurisdiction has granted approval for the supply of the medical device in that jurisdiction;
the approval by the competent regulatory agency is of a type accepted by the Authority and identified on the Authority’s website at the time of the application for the registration of the medical device; and
the medical device complies with all other conditions specified on the Authority’s website.
Subregulation 3
A Class C medical device may qualify for evaluation under an expedited abridged evaluation process, if —
at least one reference regulatory agency of a foreign jurisdiction has granted approval for the supply of the medical device in that jurisdiction;
the approval by the reference regulatory agency is of a type accepted by the Authority and identified on the Authority’s website at the time of the application for the registration of the medical device; and
the medical device complies with all other conditions specified on the Authority’s website.
Subregulation 3A
A Class D medical device may qualify for evaluation under an expedited abridged evaluation process, if —
at least 2 reference regulatory agencies, each of a foreign jurisdiction, have granted approval for the supply of the medical device in their jurisdictions;
the approval by each of the reference regulatory agencies is of a type accepted by the Authority and identified on the Authority’s website at the time of the application for the registration of the medical device; and
the medical device complies with all other conditions specified on the Authority’s website.
Subregulation 3B
A medical device is to be evaluated under a full evaluation process where —
the medical device does not qualify for evaluation under an abridged evaluation process mentioned in paragraph (2), for evaluation under an expedited abridged evaluation process mentioned in paragraph (3) or (3A), or for immediate registration under paragraph (4); or
despite the medical device qualifying for an abridged evaluation process or expedited abridged evaluation process, an applicant who wishes to register the medical device under section 30 of the Act chooses to subject the medical device to a full evaluation process.
Subregulation 3C
A Class B, C or D medical device may qualify for evaluation under a priority full evaluation process if the medical device —
is a medical device that is to be evaluated under a full evaluation process mentioned in paragraph (3B); and
is, in the Authority’s opinion, a novel medical device.
Subregulation 3D
Despite paragraph (3C), a Class B, C or D medical device that only satisfies the requirements of paragraph (3C)(a) may qualify for a priority full evaluation process if the appropriate fee specified in the Fees Regulations is paid.
Subregulation 4
The Authority may immediately register a medical device, if —
at least 2 reference regulatory agencies, each of a foreign jurisdiction, have granted approval for the supply of the medical device in their jurisdictions;
the approval by each of the reference regulatory agencies is of a type accepted by the Authority and identified on the Authority’s website at the time of the application for the registration of the medical device; and
the medical device complies with all other conditions specified on the Authority’s website.
Subregulation 4A
Despite paragraph (4), the Authority may immediately register a Class B medical device, or a Class B or C medical device that is a standalone mobile application, if —
at least one reference regulatory agency of a foreign jurisdiction has granted approval for the supply of the medical device in that jurisdiction;
the approval by the reference regulatory agency is of a type accepted by the Authority and identified on the Authority’s website at the time of the application for the registration of the medical device; and
the medical device complies with all other conditions specified on the Authority’s website.
Subregulation 5
In paragraph (4A), “standalone mobile application” means software that is designed to be used only with a mobile computing device, and which is intended to be used to control or affect the operation of —
the mobile computing device; or
another medical device that is software.
Subregulation 5A
[Deleted by S 318/2018 wef 01/06/2018]
Subregulation 6
In this regulation —
Definition
“competent regulatory agency” means any body or organisation which —
exercises a legal right to control the use or sale of medical devices within a country or territory outside Singapore;
may take enforcement action to ensure that medical devices advertised or supplied within that country or territory outside Singapore comply with the legal requirements applicable in that country or territory outside Singapore; and
is recognised by the Authority and identified on the Authority’s website at the time of the application for the registration of the medical device;
Definition
“infectious disease” has the same meaning as in the Infectious Diseases Act 1976;
Definition
“novel medical device” means a medical device that —
is intended for the purposes of the diagnosis, prevention, monitoring, treatment or alleviation of diabetes, or any disease in a specified branch of medicine, that has no other means of being diagnosed, prevented, monitored, treated or alleviated; or
represents new medical technology, as compared to other registered medical devices, that provides a clinical advantage for the diagnosis, prevention, monitoring, treatment or alleviation of diabetes, or any disease in a specified branch of medicine;
Definition
“reference regulatory agency” means a competent regulatory agency specified on the Authority’s website at the time of the application for the registration of the medical device for the purpose of an expedited abridged evaluation process under paragraph (3) or (3A) or immediate registration under paragraph (4) or (4A);
Definition
“specified branch of medicine” means any cardiovascular disease, cancer, infectious disease or ophthalmic disease.